A new shortage of a type of penicillin essential in the fight against syphilis is worrying infectious disease experts, who warn that a prolonged shortage of the drug could worsen the US epidemic of the sexually transmitted infection.
The shortage, drugmaker Pfizer announced in a letter last month, involving Bicillin LA, a long-acting injectable antibiotic also known as penicillin G benzathine. The company cited a significant increase in demand due to rising rates of syphilis infections, as well as the recent use of Bicillin as an alternative to amoxicillin, another antibiotic that is periodically in short supply and is prescribed for more general infections such as strep throat. .
Steven Danehy, a spokesman for Pfizer, said it would likely take about a year for the company to increase production by 50 percent at its Rochester, Mich., plant and eventually make enough Bicillin to meet the needs and support reserves.
Syphilis has been on the rise in the United States since 2000reaching 176,713 cases in 2021, an increase of nearly 75 percent since 2017, according to the Centers for Disease Control and Prevention.
Congenital syphilis tripled during that four-year period, to 2,855 cases, including 220 stillbirths or infant deaths. Rates are highest in infants of Native American, Native Hawaiian, Pacific Islander and Black mothers.
Bicillin is the only recommended treatment for infected pregnant women, and it is very effective in preventing transmission to the fetus if given early. Congenital syphilis has a high mortality rate, and can cause preterm birth and severe birth defects.
“It worries me that these mothers may not have access to life-saving medicine,” said Dr. Anita Henderson, a pediatrician in Hattiesburg, Miss. The state has seen a significant increase in the rate of congenital syphilis in the past five years, he said.
Of adult syphilis cases, about one-fourth are in women; just under a third are among men who only have sex with men; and about one-fifth are among men who only have sex with women.
The infection may cause injuries and a rash and, if untreated, can damage internal organs, the nervous system, eyes and ears, and can be fatal.
Pfizer also warned that its supply of a The rarely used pediatric version of Bicillin is about to run out because the company has begun using that drug’s production line to supplement the adult formula. Doctors turned to it last year as a substitute for amoxicillin during a rising number of strep throat cases.
Bicillin is also used to manage rheumatic heart disease and rheumatic fever, which are particular health risks, albeit uncommon, for children. Multiple antibiotic alternatives are available for these conditions, according to Dr. Meg Doherty, director of the global program on HIV, hepatitis and sexually transmitted infections at the World Health Organization.
To prevent bacterial infections, military recruits receive Bicillin during boot camp, where the drug is known as “peanut butter shot” because of its color and consistency. According to Dr. Ryan C. Maves, a professor of infectious diseases at Wake Forest University School of Medicine, recruits face a high risk of invasive streptococcal infection.
Alternatives to Bicillin for pregnant women are under development and evaluation but are years away from being available to them, Dr. Jeffrey Klausner, an infectious disease expert at the University of Southern California. He urged the Biden administration to pay Pfizer for about 500,000 doses to encourage production.
The Bicillin shortage is just one element of a widespread drug shortage crisis that has left doctors and pharmacists scrambling for the vital therapeutic staple and forced them to ration treatments such as chemotherapy. A recent Senate report supply problems are also characterized as a threat to national security.
Most drug companies are not particularly enthusiastic about developing antibiotics, in part because the profit margin for this class of drugs is typically lower than the next blockbuster drug that can cost billions. billion dollars.
A bipartisan group in Congress recently reintroduced $6 billion Pasteur’s lawa Netflix-like subscription model that would serve as a financial incentive for pharmaceutical companies’ research and development. While the law may address drug shortages, its primary purpose is to combat the global threat of drug-resistant pathogens.
David Harvey, executive director of the National Coalition of STD Directors, a trade association for public health associations, said rates of syphilis, chlamydia and gonorrhea everything shines “in part because of a dangerously stretched public health landscape, resulting in a lack of STI prevention, testing, and treatment.”
He and others criticized Pfizer for not producing enough of the drug because of the decades-long upward trajectory of syphilis infections. But Pfizer’s spokesman, Mr. Danehy, said the company had invested $38 million in its Michigan plant to improve manufacturing after a previous shortage of Bicillin in 2017.
Mr. Harvey also criticized the Biden administration for agreeing to the debt settlement to cut $400 million from the CDC’s budget for STI prevention.
To stretch the supply of Bicillin, the CDC recommending that doctors give preference to pregnant patients and infected or exposed infants. Other patients should be prescribed doxycycline for two to four weeks, depending on the stage of the disease. But experts have expressed concern that such individuals, including partners of pregnant women, may have trouble sticking to the twice-daily pill regimen, potentially compromising fertility. it’s effective.
Eric Tichy, division chair of supply chain management at the Mayo Clinic in Rochester, Minn., said Pfizer is likely to be alone in producing Bicillin for the US market because of the great complexity and cost of producing the drug.
But other experts objected to Pfizer’s pricing practices. “Here’s a prime example of why leaving public health to the free market can be disastrous,” said Tim Horn, director of drug access at the National Alliance of State and Territorial AIDS Directors, an advocacy group. , in an email.
“Since 2013, the price of Bicillin LA has increased by an impressive 275 percent,” said Mr. Horn.
Mr. Danehy said the list price for a 4-milliliter Bicillin LA syringe is $470, and the company has adjusted prices to ensure a proper, quality supply.
Although many health care organizations and clinics get discounts, some frontline independent clinics pay top dollar for the antibiotic.
Dr. Phyllis Ritchie, who runs a free STI clinic serving mainly gay men in Palm Springs, Calif., said the cost of a 10-pack of Bicillin shots has risen to $6,500 from $4,000. two years ago. With the clinic using about 15 to 20 of the 10-packs annually, its $225,000 annual budget can’t keep up financially, he said.
When he first began practicing medicine in the mid-1990s, Dr. Ritchie, a 10-pack cost less than $300.
“This is a crisis,” he said.
